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ODYSSEY OUTCOMES (alirocumab after acute coronary syndrome)

A large trial of 18,924 people who had had an acute coronary syndrome 1 to 12 months earlier and were taking a strong statin. Half also received alirocumab, an injected PCSK9 antibody, and half received placebo. Alirocumab lowered the rate of further heart and blood-vessel events over a median of 2.8 years.

Also called ODYSSEY OUTCOMES · ODYSSEY Outcomes

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: double. Primary purpose: prevention. (Registry values, in lower case.)
Phase
Phase 3
Enrolled
  • 18,924 participants (enrolled count) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT01663402
Started
(actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Primary completion
(actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Completion
(actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Results first posted
(actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Bosnia & Herzegovina, Hong Kong SAR China, Türkiye (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Phase 3, randomized, double-blind, placebo-controlled trial (NCT01663402), 18,924 participants enrolled, started 2012-10 and primary completion 2018-01-23. The abstract reports the primary composite in 9.5% against 11.1% (hazard ratio 0.85, 95% CI 0.78 to 0.93). Funded by Sanofi and Regeneron according to the paper; Sanofi is the registry lead sponsor and Regeneron a collaborator. The registry names atherosclerotic cardiovascular disease as the condition.

Arms

  • Placebo

    Intervention None named

    Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W

    Intervention None named

    Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).

Findings

No findings are published for this study.

Record details

Record id
cardio:odyssey-outcomes
Content hash
5a592a09ebc5299c46fee46cbc3606f753154e6f1f2cce2cc706e09c5cb116ba